Current acceptable medical practice for treating malignancies of body organs such as the kidney and the liver also involve surgical removal of the afflicted areas or, if the cancer is malignant, surgical removal of the entire organ. Since it is an organ that is involved and not a gland, about 20% to about 30% of the patients undergoing this form of therapy exhibit a sustained, favorable response.
Some organ malignancies have also been treated in situ with toxic agents such as chemotherapeutic agents and biological agents that are toxic moieties obtained from organic sources. However, it has been found that these agents can not generally be introduced into the main blood circulation of the body in sufficient strength and/or quantity to achieve desired therapeutic responses in the affected organs as their negative toxic effects on other organs and tissues of the body off-set their potential positive therapeutic effect in the afflicted organ.
Another method of treating malignant organs involves growing immune cells; i.e., Tumor Infiltrating Lymphocytic cells (TIL cells) within the affected organ in order to attack the cancerous tumors.
A further method of treating malignant organs involves the surgical removal of the cancerous tumors from the affected organ and cultivating TIL cells in sufficient quantity so that the cultivated cells can be infused beck into the patient for therapeutic treatment of the affected organ. However, this approach requires time to cultivate a sufficient quantity of the cells for adequate and effective treatment and the patient may not have the time necessary to benefit from this approach.
Although similar approaches have been used to treat diseases and malignancies of glands in living, human, host bodies, they have generally not been as successful as the treatments described above for treating organs of a host body. Treatment of diseases and malignancies of such glands as the thyroid, parathyroid and prostate with radiation or surgical removal have been generally successful, but leave the patient susceptible to adverse side affects. Treatment of diseases and malignancies of other glands such as the adrenals and pancreas is usually accomplished by surgical removal of the gland and the patient typically expires within a few months.
For example, treatment of diseases and malignancies of the pancreas by surgical removal is particularly troublesome as the surviving patient has a limited life span. The pancreas is located behind the stomach and comprises two portions: one portion secretes digestive juices which pass into the duedonum; the other portion secretes insulin which passes into the bloodstream. The pancreas can become afflicted with two major types of tumors: ductal adenocarcinoma and endocrine tumors that can be either non-functioning tumors or functioning tumors. Non-functioning tumors can result in obstruction of the bilary tract or the duedonum, bleeding into the GI tract or be evidenced as abdominal masses. Functioning tumors can cause severe symptoms such as hypoglycemia, Zolinger-Elison syndrome, hypokalemia, carcinoid syndrome, and the like.
When ductal adenocarcinoma is present, current treatment methods involve surgical removal of the affected areas it the cancer has not spread. Less than 2% of the patients undergoing this procedure survive for more than five years. When endocrine tumors are present, it is typical to surgically remove both the pancreas and the deudonum. In these instances, about 10% of the patients survive for five years.
It will be appreciated from the foregoing discussion that treating malignant or tumorous organs and glands of the body with chemotherapeutic agents has not had a significant affect. While certain drugs and biological agents have demonstrated some positive activity for a few treatments, these positive effects have been generally negated by systemic toxicity.
Processes for treating diseased tissues and organs of the body such as the liver and the kidney are known such as those disclosed in U.S. Pat. No. 6,186,146 B1 to Glickman; U.S. Pat. No. 5,411,479 to Bodden, and, U.S. Pat. No. 5,089,662 to Bodden, et.al. In general, these processes include the use of a double balloon catherer that is percutaneously inserted into the inferior vena cava of the affected organ to prepare it for the delivery of blood flowing between the organ and the heart. Blood vessels carrying blood from the organ are blocked by inflating the balloons in the catherer to prevent contaminated blood in the organ from entering the general circulation system of the body. The viscous blood from the organ contaminated with the therapeutic agent is then withdrawn from the body. The balloons in the double balloon catherer are positioned to span the vessels that carry the blood exiting from the organ and are expanded to block the vessels above and below the exit vessels to effectively isolate the blood flowing from the treated organ. The contaminated blood is removed from the body by means of an opening in a lumen provided in the catherer positioned between the expanded balloons. The contaminated blood is treated outside the body to remove the contaminants from it whereupon the cleaned, detoxified blood is returned to the general circulation system of the body.